EX-99.1 2 ea029103701ex99-1.htm PRESS RELEASE, DATED MAY 15, 2026

Exhibit 99.1

 

 

Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update

 

$5.6 Million in net revenue for the first half of fiscal 2026 from ongoing launch of LYMPHIR®

Citius Pharma raised $5 million in a registered direct offering; Citius Oncology secured up to $36.5 million in debt and equity financing

Advanced patient access with payer coverage near 100% of commercial lives and 83% of LYMPHIR target accounts on formulary or in review

 

CRANFORD, N.J., May 15, 2026 – Citius Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today reported business and financial results for the fiscal second quarter ended March 31, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR).

 

“The first half of fiscal 2026 demonstrated meaningful commercial progress at our majority-owned subsidiary Citius Oncology. In the four months of commercial sales since the December 2025 launch of LYMPHIR, Citius Oncology generated $5.6 million in net revenue at approximately 80% gross margins, advanced 83% of target accounts to formulary inclusion or active review, and secured payer coverage representing near 100% of covered commercial lives with no reimbursement denials reported to date. Importantly, major academic centers have begun to transition patients to local community infusion centers for treatment, a critical next phase of commercial scaling. These results reflect our efforts to build a durable patient access foundation upon which to drive growth,” said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharma and Citius Oncology.

 

“Subsequent to quarter end, Citius Oncology secured up to $36.5 million in combined debt and equity financing through its senior secured credit facility with Avenue Capital and the exercise of outstanding warrants, complemented by Citius Pharma’s $5 million registered direct offering. Together, these proceeds are expected to fund Citius Pharma’s activities as well as the completion of the LYMPHIR commercial field force buildout by mid-summer. This will support expanded physician engagement and broader market penetration, positioning Citius Oncology to accelerate growth as the launch matures. We believe Citius Oncology maintains sufficient inventory to support anticipated commercial demand, as well as additional demand outside the U.S., as we begin to see orders for product through our global distribution partners.”

 

“Moreover, we are encouraged by positive preliminary topline Phase 1 data from two investigator-initiated combination studies, with pembrolizumab and prior to CAR-T therapy, which reinforce LYMPHIR’s potential as a platform asset in combination regimens. At the Citius Pharma level, we also remain focused on advancing Mino-Lok and Halo-Lido with the FDA and on disciplined execution of our mission to bring first-in-class therapies to patients,” concluded Mazur.

 

Fiscal Second Quarter 2026 Business Highlights and Subsequent Developments

 

●Reported key commercial metrics of LYMPHIR launch:

 

○83% of target accounts had added or were actively progressing LYMPHIR through formulary review;

 

 

○Secured near 100% of covered commercial lives; no reimbursement denials or prior authorization barriers reported;

 

○Initial accounts placing repeat orders;

 

○Patients beginning to transition from larger academic cancer centers to community infusion centers;

 

●Announced initial shipment of LYMPHIR to Europe on April 29, 2026 through Uniphar, a leading international healthcare services company, with LYMPHIR being made available to eligible patients through Named Patient Programs (NPPs) in accordance with local regulations across 19 markets in Southern Europe, the Middle East, and additional European territories;

 

●Announced positive topline results from two investigator-initiated Phase 1 studies, including:

 

○LYMPHIR in combination with pembrolizumab in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies;

 

○LYMPHIR administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with positive topline safety and efficacy results; and,

 

●Continued FDA engagement on Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and on Halo-Lido (CITI-002), a topical formulation for hemorrhoids.

 

Fiscal Second Quarter 2026 Financial Highlights and Subsequent Events

 

●Cash and cash equivalents of $4.6 million as of March 31, 2026;

 

●Citius Pharma closed a $5 million registered direct offering in April 2026;

 

●Citius Oncology secured up to $36.5 million in financing subsequent to quarter end, consisting of:

 

○$11.5 million in gross proceeds received May 5, 2026 from the exercise of certain outstanding warrants;

 

○a loan agreement of up to $25 million from Avenue Capital Group, with $10 million in gross proceeds funded at close on May 6, 2026, and up to $15 million available in subsequent tranches pending certain revenue and liquidity milestones; and,

 

●Citius Pharma and Citius Oncology collectively expect to have sufficient funds to continue operations through November 2026;

 

●Net product revenues of $1.7 million for the three months ended March 31, 2026, compared to no revenue in the three months ended March 31, 2025, and $5.6 million for the six months ended March 31, 2026, compared to no revenue in the six months ended March 31, 2025; quarter over quarter decline reflects larger initial orders from specialty distributors at launch in the first quarter;

 

●Gross profit of $1.3 million for the three months ended March 31, 2026, and $4.5 million for the six months ended March 31, 2026; approximately 80% in both periods, reflecting continued commercial progress since the December 2025 launch of LYMPHIR;

 

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●R&D expenses of $1.6 million for the three months ended March 31, 2026, compared to $3.8 million for the three months ended March 31, 2025; and $3.2 million for the six months ended March 31, 2026, compared to $5.9 million for the six months ended March 31, 2025. The decrease in both periods primarily reflects reduced clinical development activity, as the prior-year periods included costs for a pre-license inspection batch of LYMPHIR previously manufactured;

 

●G&A expenses of $26.4 million for the three months ended March 31, 2026, compared to $4.8 million for the three months ended March 31, 2025, primarily driven by a $19.7 million one-time CMO contract cancellation charge. G&A expenses were $32.1 million for the six months ended March 31, 2026, compared to $10.2 million for the six months ended March 31, 2025;

 

●Stock-based compensation expense was $3.8 million for the three months ended March 31, 2026, compared to $2.7 million for the three months ended March 31, 2025. For the six months ended March 31, 2026, stock-based compensation was $8.1 million, compared to $5.2 million for the six months ended March 31, 2025;

 

●Recognized a gain of $3.8 million from the sale of New Jersey state net operating losses under the New Jersey Technology Business Tax Certificate Transfer Program; and,

 

●Net loss applicable to common stockholders of $21.2 million, or $(0.95) per share, for the three months ended March 31, 2026, compared to $10.9 million, or $(1.27) per share, for the three months ended March 31, 2025; and $29.5 million, or $(1.34) per share, for the six months ended March 31, 2026, compared to $20.7 million, or $(2.58) per share, for the six months ended March 31, 2025.

 

About Citius Oncology, Inc.

 

Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology’s competitive positioning. For more information, please visit www.citiusonc.com.

 

About Citius Pharmaceuticals, Inc.

 

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 71% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma’s late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.

 

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Forward-Looking Statements

 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharmaceuticals. You can identify these statements by the fact that they use words such as “will,” “anticipate,” “estimate,” “expect,” “plan,” “should,” and “may” and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to obtain, perform under and maintain financing, strategic and third party agreements and relationships, including obtaining a new bulk drug substance supplier; our ability to regain compliance with Nasdaq’s continued listing standards; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission (“SEC”) filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC’s website at www.sec.gov, including in Citius Oncology’s Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025 and as amended on January 28, 2026. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Investor Contact:

Ilanit Allen

ir@citiuspharma.com

908-967-6677 x113

 

Media Contact:

STiR-communications

Greg Salsburg

Greg@STiR-communications.com

 

– Financial Tables Follow –

 

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CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED  BALANCE SHEETS

(Unaudited)

 

   March 31,   September 30, 
   2026   2025 
ASSETS        
Current Assets:        
Cash and cash equivalents  $4,590,174   $4,252,290 
Accounts receivable, net of allowances   1,079,055    - 
Inventory   22,659,590    22,286,693 
Prepaid expenses   3,356,882    1,395,490 
Total Current Assets   31,685,701    27,934,473 
           
Operating lease right-of-use asset, net   794,518    818,694 
           
Deposits   38,062    38,062 
In-process research and development, net of accumulated amortization   90,506,250    92,800,000 
Deferred financing costs   169,252    - 
Goodwill   9,346,796    9,346,796 
Total Other Assets   100,060,360    102,184,858 
           
Total Assets  $132,540,579   $130,938,025 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current Liabilities:          
Accounts payable  $9,453,803   $13,693,692 
License payable   17,650,000    22,650,000 
Accrued expenses   24,138,264    4,190,253 
Accrued compensation   3,602,007    3,292,447 
Note payable   -    1,000,000 
Operating lease liability   171,495    88,348 
Total Current Liabilities   55,015,569    44,914,740 
           
Deferred tax liability   7,803,790    7,770,760 
Operating lease liability – noncurrent   636,667    724,925 
Total Liabilities   63,456,026    53,410,425 
           
Commitments and Contingencies          
           
Stockholders’ Equity:          
Preferred stock - $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding   -    - 
Common stock - $0.001 par value; 250,000,000 shares authorized; 22,376,427 and 18,067,744 shares issued and outstanding at March 31, 2026 and September 30, 2025, respectively   22,376    18,068 
Additional paid-in capital   329,775,214    306,336,239 
Accumulated deficit   (268,256,054)   (238,804,129)
Total Citius Pharmaceuticals, Inc. Stockholders’ Equity   61,541,536    67,550,178 
Non-controlling interest   7,543,017    9,977,422 
Total Equity   69,084,553    77,527,600 
           
Total Liabilities and Equity  $132,540,579   $130,938,025 

 

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CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE AND SIX MONTHS ENDED MARCH 31, 2026 AND 2025

(Unaudited)

 

   Three Months Ended   Six Months Ended 
   March 31,   March 31,   March 31,   March 31, 
   2026   2025   2026   2025 
Revenues  $1,667,298   $—   $5,611,409   $— 
Cost of revenues   (328,878)   —    (1,118,086)   — 
Gross Profit   1,338,420    —    4,493,323    — 
                     
Operating Expenses                    
Research and development   1,633,518    3,766,525    3,233,237    5,893,563 
Amortization of in-process research and development   1,720,312    —    2,293,750    — 
General and administrative   26,391,101    4,792,122    32,111,828    10,179,874 
Stock-based compensation – general and administrative   3,788,275    2,702,031    8,068,502    5,226,855 
Total Operating Expenses   33,533,206    11,260.678    45,707,317    21,300,292 
                     
Operating Loss   (32,194,786)   (11,260,678)   (41,213,994)   (21,300,292)
                     
Other Income (Expense)                    
Interest income   53,584    13,413    98,681    36,021 
Gain on sale of New Jersey net operating losses   3,833,277    —    3,833,277    — 
Interest expense   (33,031)   —    (188,569)   — 
Total Other Income, Net   3,853,830    13,413    3,743,389    36,021 
                     
Loss before Income Taxes   (28,340,956)   (11,247,265)   (37,470,605)   (21,264,271)
Income tax expense (benefit)   (231,210)   264,240    33,030    528,480 
                     
Net Loss   (28,109,746)   (11,511,505)   (37,503,635)   (21,792,751)
Net loss attributable to non-controlling interest   6,878,606    595,000    8,051,710    1,108,000 
                     
Net loss applicable to common stockholders  $(21,231,140)  $(10,916,505)  $(29,451,925)  $(20,684,751)
                     
Net Loss Per Share - Basic and Diluted  $(0.95)  $(1.27)  $(1.34)  $(2.58)
                     
Weighted Average Common Shares Outstanding                    
Basic and diluted (includes pre-funded warrants from the October 2025 offering)   22,376,427    8,581,207    21,931,009    8,029,834 

 

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CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE SIX MONTHS ENDED MARCH 31, 2026 AND 2025

(Unaudited)

 

   2026   2025 
Cash Flows From Operating Activities:        
Net loss  $(37,503,635)  $(21,792,751)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation expense   8,068,502    5,226,855 
Issuance of common stock for services   107,510    - 
Issuance of common stock warrant   68,597    - 
Amortization of in-process research and development   2,293,750    - 
Amortization (accretion) of operating lease right-of-use asset   24,176    110,845 
Deferred income tax expense   33,030    528,480 
Changes in operating assets and liabilities:          
Accounts receivable, net of allowances   (1,079,055)   - 
Inventory   (372,897)   (7,070,487)
Prepaid expenses   (1,961,392)   (308,791)
Accounts payable   (4,239,889)   4,441,023 
Accrued expenses   19,948,011    8,762,217 
Accrued compensation   309,560    955,048 
Operating lease liability   (5,111)   (117,767)
Net Cash Used In Operating Activities   (14,308,843)   (9,265,328)
           
Cash Flows From Investing Activities:          
License fee payments   (5,000,000)   — 
Net Cash Used in Investing Activities   (5,000,000)   — 
           
Cash Flows From Financing Activities:          
Repayment of note payable   (1,000,000)   — 
Deferred financing costs   (169,252)   — 
Proceeds from exercise of Citius Oncology pre-funded warrants   818    — 
Net proceeds from common stock offerings   20,815,161    6,039,858 
Net Cash Provided By Financing Activities   19,646,727    6,039,858 
           
Net Change in Cash and Cash Equivalents   337,884    (3,225,470)
Cash and Cash Equivalents - Beginning of Period   4,252,290    3,251,880 
Cash and Cash Equivalents - End of Period  $4,590,174   $26,410 
Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:          
Interest paid  $105,310   $— 
Operating lease right-of-use asset and liability recorded  $—   $786,697 

 

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